Welcome to RegTrials Solutions
Experts committed to facilitating the regulatory process of the pharmaceutical and biotechnology industry in Latin America.
About RegTrials
About Us
We are proud to combine our expertise to offer a comprehensive service. With strong backgrounds in regulatory law and biotechnology, we deeply understand the challenges companies face in the approval and commercialization of medical products and investigational molecules. Our team is composed of professionals passionate about ensuring your projects meet the highest regulatory standards.
Our mission
Our mission is to ensure that each medicinal product, investigational molecule, and medical device we support is approved and commercialized safely and effectively. We stay up to date with regulations across Latin America to offer personalized, efficient service tailored to each client’s specific needs.
What We Do
Our focus is on providing comprehensive advice for the preparation, customization, and finalization of regulatory packages for clinical trials, from Phase I to Phase IV — including Start-Up, maintenance, and study closure. We work closely with our national and international clients to ensure the correct submission of these packages to local, provincial, central ethics committees, and the Ministry of Health in each LATAM country.
Servicios
Medicinal Products
– Registration, modification, transfer
– Regulatory reports (Due Diligence)
– Strategic regulatory planning
– Support with National Health Authorities
Medical Devices and In Vitro Diagnostics
– HELENA System
– Registration, modification, revalidation
– Support with National Health Authorities
Clinical Trials
– Regulatory packages (Start-Up, maintenance, closure)
– Customized Informed Consent Forms
– Amendments and site inclusion
– Liaison with National Authorities
Regulatory Audits
– Document compliance review
Importation
– Review of commercial invoices
– Platform submission package
– Storage and distribution support
Health isn't everything, but without health, everything else is nothing.
Arthur Schopenhauer